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Interchangeable
Anti-Asphyxia Nebulizer
Attachment Elbow
22mm Female
2797
Latex Free
Single Patient Use
Caution:
Federal Law (USA) restricts this device to sale
by or on the order of a licensed physician.
M
Pulmodyne Inc.
2055 Executive Drive
Indianapolis, IN 46241 USA
www.pulmodyne.com
Interchangeable
Anti-Asphyxia Nebulizer
Attachment Elbow
22mm Female
2797
Latex Free
Single Patient Use
Caution:
Federal Law (USA) restricts this device to sale
by or on the order of a licensed physician.
M
Pulmodyne Inc.
2055 Executive Drive
Indianapolis, IN 46241 USA
www.pulmodyne.com
Intended Use
The Interchangeable Anti-Asphyxia Nebulizer Attachment Elbow is an accessory to the BiTrac Select Full
Face Mask. Use of this elbow with these masks is an accessory for use with CPAP and Bilevel systems
used in the treatment of adult Obstructive Sleep Apnea (OSA) and/or ventilator support. A minimum
pressure of >3.0cm of H
Note
When NOT in use ensure the nebulizer adapter port is sealed.
Contraindications
Warnings
Before Use
Verify entrainment valve function on Interchangeable Anti-Asphyxia Nebulizer Attachment Elbow
• With the valve unit turned OFF; the entrainment valve flap should be open, allowing user to breathe
room air
• Turn CPAP or Bilevel unit ON
• The flap valve should close, allowing the user to receive airflow from the unit
• If the valve does not function in this manner; replace the elbow
EN-Medical Device
• Check the valve before each use for malfunction or blockage caused by patient secretions
Use of Interchangeable Elbow Feature:
P
Bayonet Lock References:
Figure A.
Made in USA
Intended Use
The Interchangeable Anti-Asphyxia Nebulizer Attachment Elbow is an accessory to the BiTrac Select Full
Face Mask. Use of this elbow with these masks is an accessory for use with CPAP and Bilevel systems
used in the treatment of adult Obstructive Sleep Apnea (OSA) and/or ventilator support. A minimum
pressure of >3.0cm of H
Note
When NOT in use ensure the nebulizer adapter port is sealed.
Contraindications
Warnings
Before Use
Verify entrainment valve function on Interchangeable Anti-Asphyxia Nebulizer Attachment Elbow
• With the valve unit turned OFF; the entrainment valve flap should be open, allowing user to breathe
room air
• Turn CPAP or Bilevel unit ON
• The flap valve should close, allowing the user to receive airflow from the unit
• If the valve does not function in this manner; replace the elbow
• Check the valve before each use for malfunction or blockage caused by patient secretions
EN-Medical Device
Use of Interchangeable Elbow Feature:
P
Bayonet Lock References:
Figure A.
Made in USA
O at the mask is required.
2
1. This device should not be used on uncooperative or unresponsive patients.
2. This device may not be suitable for use on patients unable to remove the mask or
are taking medication which may cause vomiting.
1. This elbow should be used only for a nebulizer treatment while in the presence of trained
medical personnel.
2. This mask does not have an integral leak port; therefore a separate exhalation device must be
part of the circuit. Utilize the equipment manufacturer's recommended exhalation
port in the designed circuit.
3. This device is designed to be used only in conjunction with a BiTrac Select Full Face
Interchangeable Elbow compatible mask.
4. To avoid aerosolized medication coming in contact with the eyes, the Interchangeable
Anti-Asphyxia Nebulizer Attachment Elbow should NOT be used on the BiTrac Select
Max Shield mask.
1. Remove the existing elbow from the mask by holding the adapter ring and twisting the elbow
counter clockwise to disengage the bayonet lock (Refer to Figure B.)
2. Gently pull the elbow from the mask. (Refer to Figure C.)
3. Gently press the desired Interchangeable Compatible Elbow into the mask adapter ring and turn
clockwise until fully seated. Do not use excessive force.
Figure B.
O at the mask is required.
2
1. This device should not be used on uncooperative or unresponsive patients.
2. This device may not be suitable for use on patients unable to remove the mask or
are taking medication which may cause vomiting.
1. This elbow should be used only for a nebulizer treatment while in the presence of trained
medical personnel.
2. This mask does not have an integral leak port; therefore a separate exhalation device must be
part of the circuit. Utilize the equipment manufacturer's recommended exhalation
port in the designed circuit.
3. This device is designed to be used only in conjunction with a BiTrac Select Full Face
Interchangeable Elbow compatible mask.
4. To avoid aerosolized medication coming in contact with the eyes, the Interchangeable
Anti-Asphyxia Nebulizer Attachment Elbow should NOT be used on the BiTrac Select
Max Shield mask.
1. Remove the existing elbow from the mask by holding the adapter ring and twisting the elbow
counter clockwise to disengage the bayonet lock (Refer to Figure B.)
2. Gently pull the elbow from the mask. (Refer to Figure C.)
3. Gently press the desired Interchangeable Compatible Elbow into the mask adapter ring and turn
clockwise until fully seated. Do not use excessive force.
Figure B.
Operating Specifications: 5°C to 40°C at
humidity range of 15% to 95%
Storage Specifications: -20°C to 60°C at
relative humidity up to 95% non-condensing
Figure C.
Operating Specifications: 5°C to 40°C at
humidity range of 15% to 95%
Storage Specifications: -20°C to 60°C at
relative humidity up to 95% non-condensing
Figure C.
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Resumen de contenidos para Pulmodyne BiTrac Select

  • Página 1 Utilize the equipment manufacturer’s recommended exhalation port in the designed circuit. 3. This device is designed to be used only in conjunction with a BiTrac Select Full Face Interchangeable Elbow compatible mask. 4. To avoid aerosolized medication coming in contact with the eyes, the Interchangeable Anti-Asphyxia Nebulizer Attachment Elbow should NOT be used on the BiTrac Select Max Shield mask.
  • Página 2 Vernebler 22 mm, weiblich Verwendungszweck Der Austauschbares Aufsatzbogenstück für Anti-Asphyxie-Vernebler ist ein Zubehörteil für die BiTrac Select Vollgesichtsmaske. Der Krümmer wird für diese Masken als Zubehörteil zur Verwendung mit CPAP- oder Bilevel-Systemen bei der Behandlung obstruktiver Schlafapnoe (OSA) bei Erwachsenen und/oder für die unterstützende Beatmung verwendet.
  • Página 3 2. Denne maske har ikke nogen indbygget udåndingsåbning; derfor skal der tilsluttes en separat udåndingsanordning til kredsløbet. Anvend det af udstyrsproducenten anbefalede udåndingsudstyr i det pågældende kredsløb. 3. Udstyret er udelukkende designet til brug sammen med en BiTrac Select hel ansigtsmaske, som er kompatibel med udskifteligt vinkelstykke.
  • Página 4 Indicaciones de uso El Codo de acoplamiento intercambiable para nebulizador antiasfixia es un accesorio de la Mascarilla Oronasal BiTrac Select. El conjunto formado por el codo y estas mascarillas es un accesorio para utilizar con sistemas de CPAP o de dos niveles en el tratamiento de adultos con apnea obstructiva del sueño (AOS) o soporte ventilatorio. Es precisa una presión mínima de >3 cm de H...
  • Página 5 Utilisation prévue Le Embout interchangeable en forme de coude pour nébuliseur anti-asphyxie est un accessoire qui s’adapte au masque respiratoire complet BiTrac Select. Le raccord coudé adaptable sur ce masque est un accessoire prévu pour les systèmes CPAP et Bi-level utilisés pour traiter l’apnée obstructive du sommeil (AOS) chez l’adulte et/ou dans le cadre d’une assistance respiratoire.
  • Página 6 3. Tämä laite on suunniteltu käytettäväksi ainoastaan vaihdettavan mutkakappaleen kanssa yhteensopivan BiTrac Select -kokokasvomaskin kanssa. 4. Jotta lääkesumutetta ei joudu silmiin, vaihdettavaa hapenpuutteen estävää sumuttimen kulmaosaa EI saa käyttää BiTrac Select MaxShield -naamarin kanssa. Ennen käyttöä Varmista vaihdettavan anti-asfyksiamutkakappaleen ottoventtiilin toiminta.
  • Página 7 Προοριζόμενη χρήση Ο Εναλλάξιμη γωνία αντιασφυξίας νεφελοποιητή είναι εξάρτημα της πλήρους κάλυψης προσώπου BiTrac Select. Η χρήση του γωνιακού συνδέσμου με τις μάσκες αυτές αποτελεί μέρος της χρήσης με τα συστήματα CPAP και Bilevel, τα οποία χρησιμοποιούνται στη θεραπεία της αποφρακτικής άπνοιας ύπνου (ΑΑΥ) σε ενήλικες ασθενείς ή/και ως αναπνευστική...
  • Página 8 Uso previsto Il Raccordo a gomito intercambiabile con valvola anti-asfissia per nebulizzatore è un accessorio della maschera facciale totale BiTrac Select. L’utilizzo del gomito con queste a maschera è un’opzione con sistemi CPAP e Bilevel per il trattamento delle apnee ostruttive nel sonno (OSAS) e/o il supporto ventilatorio. È necessaria una pressione minima di >3,0 cm di H...
  • Página 9 Tiltenkt bruk Utskiftbart kvelningshindrende vinkelrør for forstøvere er et tilbehør til BiTrac Select full ansiktsmaske. Bruk av albuen med disse maskene er et tilbehør til CPAP og totrinnssystemer som brukes i behandling av obstruktiv søvnapné (OSA) hos voksne og/eller ventilasjonsstøtte. Det kreves et minimumstrykk på >3,0 cm med H i masken.
  • Página 10 3. Dit hulpmiddel is uitsluitend ontworpen voor gebruik in combinatie met een BiTrac Select volledig gezichtsmasker dat compatibel is met een uitwisselbaar elleboogstuk. 4. Om te voorkomen dat medicatie in aerosolvorm in aanraking komt met de ogen, mag de verwisselbare aansluitelleboog voor de anti-asfyxievernevelaar NIET op het BiTrac Select MaxShield-masker worden gebruikt.
  • Página 11 Utilização prevista O Cotovelo de ligação para nebulizador anti-asfixia intercambiável é um acessório da Máscara Facial Completa BiTrac Select. O cotovelo deve ser utilizado como acessório nos sistemas CPAP e de dois níveis no tratamento de Apneia Obstrutiva do Sono (AOS) em adultos e/ou para suporte ventilatório. É necessário que exista uma pressão mínima >3,0 cm de H2O na máscara.
  • Página 12 Przeznaczenie Wymienne kolanko do nebulizatora zapobiegające utracie przytomności z powodu braku tlenu jest urządzeniem dodatkowym do maski pełnotwarzowej BiTrac Select. Użycie kolanka z tymi maskami stanowi element dodatkowy do stosowania z systemami CPAP lub przeznaczonymi do terapii dwupoziomowej stosowanymi w terapii obturacyjnego bezdechu sennego (OSA) u pacjentów dorosłych i/lub wspomagania oddechowego.
  • Página 13 Avsedd användning Det Utbytbar vinkelkoppling med kvävningsskydd till nebulisator är ett tillbehör till BiTrac Select Full Face-mask. Användning av knäröret tillsammans med denna mask är ett tillbehör som kan användas med CPAP- och Bilevel-system vid behandling av obstruktiv sömnapné (OSA) hos vuxna och/eller som ventilationsstöd. Det krävs ett minimitryck på > 3,0 cm H masken.
  • Página 14 Kullanım Amacı Değiştirilebilir Anti-Asfeksi Nebülizer Ek Dirsek, BiTrac Select Tam Yüz Maskesinin yardımcı bir parçasıdır. Bu dirsek, Yetişkin Obstrüktif Uyku Apnesi (OSA) tedavisinde ve/veya suni solunum cihazı desteğinde kullanılan CPAP ve Bilevel sistemleri ile birlikte yardımcı bir parça olarak bu maskelerle birlikte kullanılır. Maskede minimum basıncın >3,0 cm'lik H O olması...
  • Página 15 Notes 15 of 15 Notes 15 of 15...